Transcript CTSI: Breaking Down Your Barriers to Research Through

Conflict of Interest
management & the responsible
conduct of research
Khrys X. Myrddin, MPPM
Associate Director
COI Office
A partner in promoting integrity in research, teaching, and administration
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Today’s agenda
• A general overview of conflicts of interest (COI).
• Discuss why properly identifying and managing COIs
is important.
• Management of research-related COIs
• NEW review requirements for PHS-funded research
• Implications of COI management
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Scenario 1
• Professor A. E. Moniz is a consultant for e-SCOPE (his
contract is for $35,000 in this current year);
• e-SCOPE wants to sponsor human subject research
at the University to evaluate new technologies for
measuring the architecture of the brain
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Scenario 1 - Questions
• Do you have any concerns with Dr. Moniz being the
PI of the clinical trial sponsored by e-SCOPE?
• What kind of information, if any, would you want as
a potential research subject in the study?
• What kind of information would you want as a coinvestigator on the study?
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Myth/fact?
• You can’t have a financial conflict of interest with
federal research.
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Scenario 2
• Dr. Ivette Semmelweiss developed a new method for
treating OCD, which was patented by the University
and licensed to Rehab, Inc., she receives royalties for
the IP through Pitt;
• Dr. Semmelweiss is conducting federally sponsored
research to further evaluate the technology.
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Scenario 2 - Questions
• Do you think Dr. Semmelweis has a conflict of
interest?
• If so, would the type of research being conducted
influence how you think it should be managed?
• What kind of information would you want as a coinvestigator on the study?
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What is a conflict of interest?
• A potential Conflict of Interest (COI) may exist if an
individual’s outside interests (especially financial)
may affect, or perceive to affect, his/her research,
teaching, or administrative activities at the
University.
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Why should you care about COI?
Conflicts of interest can affect…
• An investigator’s role in studies;
• The willingness of potential research subjects to
participate in research;
• How the research results are viewed by the scientific
community and the general public;
• The reputation of individual researchers and
research institutions.
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Importance of COI management
If conflicts of interest are not managed…
• protection of human subjects may be compromised;
• integrity of research may be at risk;
• the public may lose trust in the University and its
research findings;
• University may lose public support and funding for
research;
• the investigator/faculty member may lose the
respect of the academic community;
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Importance of COI management
• violation of scientific norms may result;
• research results may be excessively delayed or not
published;
• there may be a negative impact on students,
trainees, and/or junior faculty;
• University resources may be improperly used;
• increased government regulations may result;
• scandals or negative media attention may occur….
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From the headlines
The Chronicle of Higher Education
NIH Halts Study at Emory Over Concerns About Drug
Company’s Payments
The National Institutes of Health has halted a $9.3million five-year research project at Emory
University, pending an investigation into potential
conflicts of interest by the project’s former leader…
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From the headlines
Researchers Fail to Reveal Full Drug Pay
By GARDINER HARRIS and BENEDICT CAREY
PUBLISHED: JUNE 8, 2008 in The New York Times
[Dr. Joseph Biederman], a Harvard child psychiatrist
whose work has helped fuel an explosion in the use
of antipsychotics in children earned at least $1.6
million in consulting fees from drugmakers from
2000 to 2007 but for years did not report much of
the income to university officials, according to
information given to Congressional investigators…
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Ban or manage?
“The University recognizes the obligation to make the
special knowledge and intellectual competence of its
faculty members available to government, business,
labor, and civic organizations; as well as the potential
value to the faculty member and the University.”
(Policy 02-06-01)
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Manage! – University policies
02-06-01: Outside Employment: This policy establishes
the conditions under which faculty members may
perform professional services outside the University.
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Manage! – University Policies (02-06-01)
• Permission from the department chairman, dean or
campus president
• No use of University name, property, or facilities
• Time given to outside activities is not to exceed one
day per week on average
• Fees for outside work are commensurate with
services provided and the faculty member's
professional standing
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Manage! – University Policies
11-01-03 Conflict of Interest Policy for Faculty, Scholars,
Researchers, Research Staff/Coordinators
• The opportunity for University personnel to receive
financial…rewards from [relationships with industry]
…is not intrinsically unacceptable, as long as they do
not adversely affect the objectivity, integrity, or
professional commitment of investigators and
scholars.
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Manage! – University Policies (11-01-03)
• It is the potential for conflicts of interest that must
be addressed to ensure that they do not threaten
the integrity of the university’s scholarship,
research, instruction, evaluation, and
administration.
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Manage! – University Policies (11-01-03)
• Purpose – to assure that:
– the advantages of interactions w/industry are realized
without the loss of the fundamental values of
objectivity and freedom of inquiry in research and
scholarship;
– University’s research programs and reputation are not
compromised; and
– no one unfairly benefits from the University’s public
trust or reputation
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Manage! – University Policies (11-01-03)
• Requires disclosure of financial relationships to the
University using the Superform system
– Everyone files between Jan 1st – April 15th
– Disclosures must be kept up-to-date throughout the year
• Separate UPMC & Pitt COI systems
– University: Superform https://coi.hs.pitt.edu/
– UPMC: My Hub > Human Resources tab > COI
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Annual COI filing – Faculty/Researcher
forms
• All regular full-time faculty
• Anyone, regardless of title or position, who engages
in research at the University of Pittsburgh
• Anyone who is or expects to be an investigator on a
PHS-funded project must complete the PHS
Faculty/Researcher form, instead of the regular
form
– Only complete the Faculty/Researcher form that
applies to you, not both
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Manage! – University Policies (11-01-03)
• Outlines COI management of regulated research
• Outlines restrictions on faculty interaction with
Licensed Start-up Companies
– Not publicly-traded
– Option or license to University intellectual property
– University or one or more of its employees have
ownership interest
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Agencies of the Public Health Service
(PHS)
• Administration for Children and Families (ACF)
– Administration on Children, Youth and Families (ACYF)
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Administration for Community Living (ACL)
Agency for Healthcare Research and Quality (AHRQ)
Centers for Disease Control and Prevention (CDC)
Centers for Medicare & Medicaid Services (CMS)
Food and Drug Administration (FDA)
Health Resources and Services Administration (HRSA)
Indian Health Service (IHS)
National Institutes of Health (NIH)
– National Cancer Institute
• Substance Abuse and Mental Health Services Administration
(SAMHSA)
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PHS COI regulations
• New regulations for “promoting objectivity in
research”– 42 CFR Part 50, subpart F (grants) & 45
CFR Part 94 (contracts)
– Lowered reporting thresholds
– Placed responsibility for determining if financial interests
constitute Financial Conflicts of Interest w/PHS-funded
research w/institution
– Requires reporting of sponsored & reimbursed travel
related to institutional responsibilities
– Additional training requirements
– Managed FCOIs with PHS-funded research to be disclosed
on publicly-accessible website
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PHS COI regulations
• Policy 11-01-03 revised August 24, 2012 to reflect
new PHS COI regulations
• See COI website for summary of changes and
information regarding new requirements
– http://www.coi.pitt.edu/PHS/index.htm
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PHS COI review – grants & contracts
• Submissions: the Office of Research will check that
PI/PD and all Senior/Key personnel have PHS
Faculty/Researcher forms on file & have completed
the CITI PHS COI Training module.
• Awards: the Office of Research will refer to the COI
Office awards on which Investigators have reported
outside financial interests on PHS Faculty/Researcher
forms.
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Manage! – Industry Relationships Policy
• Ended participation in Speaker’s Bureaus
• Limits site access for Industry and banned the provision of
gifts and meals by Industry
• Outlines criteria for faculty participation in Industrysponsored events
• Explicitly bans sales, marketing, and promotional activities,
and otherwise proscribes faculty interactions with Industry
• AKA: Policy on Conflicts of Interest and Interactions between
representatives of Certain Industries and Faculty, Staff and Students of
the Schools of the Health Sciences and Personnel Employed by UPMC at
all Domestic Locations
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Not me! Yes, YOU (and everyone else).
• Daylain Cain, PhD and Allan S. Detsky, MD, PhD.
“Everyone’s a Little Biased (Even Physicians),” JAMA,
June 25, 2008—Vol. 299, No. 24
– “Conflicts of interest are problematic, not only
because they are widespread, but also because most
people incorrectly think that succumbing to them is
due to intentional corruption, a problem for only a
few bad apples.”
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Not me! Yes, YOU (and everyone else).
• The Ethical Brain, Post Hoc
– People think they have good reasons for their beliefs,
but these reasons are often made up after the fact.
• Subconscious Conflicts
– ‘Motivated reasoning’ – individuals use different
strategies to evaluate propositions depending on
whether the hypothesis is desirable or
threatening/disagreeable to them.
– Many of these processes have been shown to be
unintentional, difficult to control, and resistant to
incentives for accuracy.
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Not me! Yes, YOU (and everyone else).
• Is disclosure the answer?
– Not quite – disclosure can actually “have the perverse
effect of making professionals more biased rather
than less.” Disclosure (alone) is not the solution.
– “Transparency is well and good, but accuracy and
objectivity are even better. [The profession] does not
have to keep confessing its sins. It just has to stop
committing them.”
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Not me! Yes, YOU (and everyone else).
• “Researchers and clinicians have been taught that
scientific experiments that involve observations or
judgments must be protected from the unintentional
influences of bias.”
– E.g., double-blinded studies
• “Bias is not a crime, is not necessarily intentional,
and is not a sign of lack of integrity; rather it is a
natural human phenomenon.”
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Managing COIs with research
• The COI Committee is responsible for managing
potential conflicts related to Human subject research
(IRB) and Animal research (IACUC)
• No longer ask COI questions on protocols for
– CORID (Research and Clinical Training on Decedents)
– IBC (Institutional Biosafety Committee/rDNA)
– hSCRO (Human stem cell research)
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Managing COIs with research
• COI questions that appear on protocol applications
apply to all investigators and research personnel
– There are NEW questions for PHS-funded studies
• Questions reflect SFI categories & thresholds
• PI is responsible for ensuring that all investigators
and study personnel review these questions
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Managing COIs with research
• 'Investigator' means any member of the study team
who participates in the design, conduct, or
reporting of this research, as well as his/her spouse,
registered domestic partner, dependents, or other
members of his/her household.
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Managing COIs with research
• Reporting must be kept current
– Whenever new outside interests are accrued,
investigators should notify the COI Office and the
appropriate regulatory committee (e.g., IRB, IACUC),
and update their Faculty/Researcher COI forms
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Human subject research (IRB)
• NB: Protocols that are “exempt” or receive a “not
human subjects research” designation are treated
like bench research (i.e., not subject to regulated
research section of COI policy)
• Non-PHS funded protocols
– Answering “yes” to any of the COI questions in section
7.3 requires invocation of Standard COI Management
Plan (SMP) for Human Subject Research
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Human Subject Research (IRB)
• PHS funded protocols
– CMP for “yes” answers to COI questions will depend
on nature/value of SFI
– SFIs with value > $5,000, but < $10,000 and those
arising from reimbursed or sponsored travel, COI
Office will work with department chair to develop
CMP
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Animal research (IACUC)
• Non PHS-funded
– “PI-exclusion rule” applies to equity, remuneration,
and Licensed Start-up companies.
• Management plan similar to SMP, less the items
specific to human subject research
– Financial interest only in the IP being evaluated are
reviewed on a case-by-case basis.
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Animal research (IACUC)
• PHS-funded
– “PI-exclusion rule” applies to SFIs in publicly-held
entities (> $10K); any equity in nonpublic entities,
remuneration from nonpublic entities (> $10K), and
Licensed Start-up companies.
• Management plan similar to SMP, less the items
specific to human subject research
– Financial interest only in the IP being evaluated are
reviewed on a case-by-case basis.
– COI Office works with dept. chair to develop CMPs for
travel FCOIs and SFIs < $10K
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Managing COIs with research
• The “minimum required CMP” for PHS-funded research
– The investigator will disclose the existence of his/her SFI in
any abstracts, presentations, press releases, or
publications resulting from the PHS-funded research, and
in any proposals or applications for research funding of
commercial interest to the company.
– Other individuals (students, staff, or other faculty
members) engaged in the PHS-funded research project
with the investigator, should be notified of the existence
of his/her SFI through the use of the standard Notification
form
– Students will be engaged in the project only with the
approval of their department chair or dean.
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Managing COIs with research
• All managed FCOIs will be reported to the
appropriate funding source
• In the case of PHS-funded research, this information
will also be posted on the University’s COI website,
as required by federal regulation
– http://www.coi.pitt.edu/PHS/FCOIList.htm
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Examples & discussion
• In the following scenarios, think about what issues
might arise as a result of the investigator’s financial
interest.
• Think about yourself as the person with the financial
relationship and as someone working with that
person.
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Examples of research COIs
• Professor A. E. Moniz is a consultant for e-SCOPE (his
contract is for $35,000 in this current year);
• e-SCOPE wants to sponsor human subject research
at the University to evaluate new technologies for
measuring the architecture of the brain
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Author
Examples of research coiS
• What management plan would be implemented?
• Why do you think certain elements are required?
• How do you think potential research participants
would feel about reading the COI disclosure language
in the informed consent document?
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Author
Examples of research COIs
• Dr. Ivette Semmelweiss developed a new method for
treating OCD, which was patented by the University
and licensed to Rehab, Inc.,; she receives royalties
for the IP through Pitt;
• Dr. Semmelweiss is conducting federally sponsored
research to further evaluate the technology.
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Author
Examples of research COIs
• Do you think Dr. Semmelweiss has a COI?
• What are the potential benefits of COI management
in this scenario?
• What would you think if you received a form
notifying you that one of the investigators on a study
you are working on has a financial interest in the
research?
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Questions?
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Resources & assistance
COI website: www.coi.pitt.edu
– For information about the Pitt/UPMC combined
disclosure form, see COI Filing Process > Pitt & UPMC
Electronic COI Filing Systems
– For information on engaging in consulting activities, see
Industry Relationships Policy > Policy Compliance Tools, as
well as the IRP FAQ page
NIH FCOI website:
http://grants.nih.gov/grants/policy/coi/
– Links to new regulations
– Educational tutorial & FAQs
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Resources & assistance
COI Office Staff
COI Committee
David T. Wehrle, CPA, CFE, CIA
Director/COI Office
412-383-1774 [email protected]
Jerome L. Rosenberg, PhD
Chair
412-624-3007 [email protected]
Khrys X. Myrddin, MPPM
Associate Director/COI Office
412-383-2828 [email protected]
Benjamin T. West
Compliance Coordinator/COI Office
412-383-1735 [email protected]
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RCR Training Evaluation Questions
Thank you for your participation
CTSI
Responsible Conduct of Research Training
Center
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This program enabled me to feel more
confident in my knowledge and
understanding of this topic.
A. Strongly Disagree
B. Disagree
C. Somewhat Disagree
D. Neither Agree nor Disagree
E. Somewhat Agree
F. Agree
G. Strongly Agree
Response
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Title
Counter
Author
Through this program I have gained
practical tools or skills that I can apply
to my research.
A. Strongly Disagree
B. Disagree
C. Somewhat Disagree
D. Neither Agree nor Disagree
E. Somewhat Agree
F. Agree
G. Strongly Agree
Response
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Title
Counter
Author
After attending this program I feel that I
am better able to access resources at
Pitt for my research.
A. Strongly Disagree
B. Disagree
C. Somewhat Disagree
D. Neither Agree nor Disagree
E. Somewhat Agree
F. Agree
G. Strongly Agree
Response
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Title
Counter
Author
After attending this program, I feel more
confident to advance the progress of my
research.
A. Strongly Disagree
B. Disagree
C. Somewhat Disagree
D. Neither Agree nor Disagree
E. Somewhat Agree
F. Agree
G. Strongly Agree
Response
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Title
Counter
Author
Overall, my evaluation of this program is:
A. Poor
B. Fair
C. Neutral
D. Good
E. Excellent
Response
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Counter
Author
What is your role in research ? (choose
all that apply)
0
0
0
0
0
0
0
0
0
0
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A.
B.
C.
D.
E.
F.
G.
H.
I.
J.
Department chair or senior faculty
Assistant or Associate Professor
Postdoctoral fellow
Medical fellow
Medical resident
Medical student
Graduate student
Research coordinator
Research staff
other
In general, where in the research
process do you encounter the biggest
barriers?
A. Designing the study (protocol development,
statistics, collaborations, grant writing, etc.)
B. Launching the study (regulatory, contracts,
personnel, equipment, etc)
C. Conducting the study (recruitment, data
collection and analysis, publication, etc.)
Response
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Title
Counter
Author
How many years have you been
involved in research?
A. <1
B. 1-5
C. 6-10
D. 11-15
E. >15
Response
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Title
Counter
Author